NCT04508218

Brief Summary

Burn injury causes continuous catabolism of the skeletal muscle resulting in decreased muscle strength, muscle mass and impairment of functional mobility. Purpose: The purpose of this study is to investigate the efficacy of combination of exercise training and protein supplementation on lean body mass (LBM) and muscle strength in patients with severe burn.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2020

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
Last Updated

August 11, 2020

Status Verified

August 1, 2020

Enrollment Period

6 months

First QC Date

August 5, 2020

Last Update Submit

August 7, 2020

Conditions

Burns

Keywords

Exercise trainingProtein supplementationMuscle strengthLean body massBurn

Outcome Measures

Primary Outcomes (1)

  • lean body mass

    The QDR 4500A densitometry system DXA (Hologic Inc., Bedford, USA) was used according to the manufacturer instructions for calculating LBM

    after 12 week of intervention

Secondary Outcomes (1)

  • muscle strength

    after 12 week of intervention

Study Arms (4)

Protein+ Exercise group

EXPERIMENTAL

Received oral protein supplementation, exercise program and traditional burn care

Dietary Supplement: whey protein supplementation powder (Inkospor X-TREME; France)Other: Exercise training programOther: traditional burn care

Protein group

EXPERIMENTAL

Received oral protein supplementation and traditional burn care

Dietary Supplement: whey protein supplementation powder (Inkospor X-TREME; France)Other: traditional burn care

Exercise group

EXPERIMENTAL

Received exercise program and traditional burn care

Other: Exercise training programOther: traditional burn care

Control group

OTHER

Received traditional burn care

Other: traditional burn care

Interventions

whey protein supplementation powder (Inkospor X-TREME; France)DIETARY_SUPPLEMENT

Protein requirements for burned adults are estimated as 1.5-2.0 g/kg/day. The participants asked to take the calculated serving of whey protein dissolved in 150ml of water two times / day in the morning and in the evening

Protein groupProtein+ Exercise group
Exercise training programOTHER

After healing of the burn (6 weeks after injury), participants in group A and group C started resisted exercise program with a qualified therapist for 1 hour three times/week on nonconsecutive days over 12 weeks. In addition, aerobic exercises were conducted on the treadmill. Peak oxygen consumption was assessed for all patients by using the exercise test on treadmill before participation in aerobic exercises.

Exercise groupProtein+ Exercise group
traditional burn careOTHER

ROM exercises, stretching, ADL activities and scar management

Control groupExercise groupProtein groupProtein+ Exercise group

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healed deep partial-thickness thermal burn
  • \> 30% of TBSA and
  • the exercise program started after healing of the burn (after burn injury by 6 weeks)

You may not qualify if:

  • conditions that may affect on participation in the exercise program as a recent coronary disease, uncontrolled hypertension, orthopedic problems limiting exercise, abnormal cardiac stress test, pregnant women, refusal to participate in a physical activity program,
  • presence of psychological or cognitive disorders (aggressive behavior, impulsivity, dementia)
  • food intolerance to milk protein products.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nesma Morgan Allam

Tanta, Egypt

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Nesma M Allam, PhD

    lecturer at faculty of physical therapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 5, 2020

First Posted

August 11, 2020

Study Start

August 15, 2019

Primary Completion

February 2, 2020

Study Completion

February 25, 2020

Last Updated

August 11, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share

results of the study

Shared Documents
STUDY PROTOCOL
Time Frame
6 months after puplication
Access Criteria
study protocol

Locations

EG(1)